Systemic Lupus ErythematosusPhase 1/2NCT05465707
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A Phase 1/2 study testing CM313 2 mg/kg, CM313 4 mg/kg and CM313 8 mg/kg in people with Systemic Lupus Erythematosus, run by Keymed Biosciences Co.Ltd.
Trial summary
A study of CM313 in subjects with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CM313 2 mg/kg, CM313 4 mg/kg and CM313 8 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 65 years old.
- Positive autoantibody serology test at screening.
- Contraception.
- Voluntarily sign the ICF.
Who cannot join
- With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
- Possibly active Mycobacterium tuberculosis infection.
- With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
- Heavy drinking in the 3 months prior to screening.
- With depression or suicidal thoughts.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus
A study of CM313 in subjects with systemic lupus erythematosus
Read the detailed description
This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.
About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.
The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg, CM313 16 mg/kg, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313 2 mg/kgBiological
Once 1 week, intravenous infusion.
CM313 4 mg/kgBiological
Once 1 week, intravenous infusion.
CM313 8 mg/kgBiological
Once 1 week, intravenous infusion.
CM313 16 mg/kgBiological
Once 1 week, intravenous infusion.
PlaceboBiological
Once 1 week, intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| CM313 2 mg/kg | Experimental | Once 1 week, intravenous infusion. Receives: Biological: CM313 2 mg/kg |
| CM313 4 mg/kg | Experimental | Once 1 week, intravenous infusion. Receives: Biological: CM313 4 mg/kg |
| CM313 8 mg/kg | Experimental | Once 1 week, intravenous infusion. Receives: Biological: CM313 8 mg/kg |
| CM313 16 mg/kg | Experimental | Once 1 week, intravenous infusion. Receives: Biological: CM313 16 mg/kg |
| Placebo | Placebo comparator | Once 1 week, intravenous infusion. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs).
Safety parameters
Measured: Baseline up to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465707
- Sponsor's protocol ID
- CM313-106001
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao J, Lin C, Xie Q, Shu Q, Cui Y, Luo H, Fan W, Huang A, Zhao Y, Fu Z, Xie C, Wu H, Yang N, He L, Feng P, Zhang T, Zhou H, Liu W, Hou Q, Mao X, Sun J, Chen B, Zeng X. Anti-CD38 monoclonal antibody CM313 for systemic lupus erythematosus: a randomized, double-blind, placebo-controlled phase Ib/IIa trial. Signal Transduct Target Ther. 2025 Nov 26;10(1):383. doi: 10.1038/s41392-025-02487-2.
PubMed 41290616
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05465707
- Acronym / sponsor ID
- CM313-106001
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of CM313 in subjects with systemic lupus erythematosus
Detailed description
This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.
About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.
The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CM313 2 mg/kg | Experimental | Biological: CM313 2 mg/kgOnce 1 week, intravenous infusion. |
| CM313 4 mg/kg | Experimental | Biological: CM313 4 mg/kgOnce 1 week, intravenous infusion. |
| CM313 8 mg/kg | Experimental | Biological: CM313 8 mg/kgOnce 1 week, intravenous infusion. |
| CM313 16 mg/kg | Experimental | Biological: CM313 16 mg/kgOnce 1 week, intravenous infusion. |
| Placebo | Placebo comparator | Biological: PlaceboOnce 1 week, intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ≤ age ≤ 65 years old.
- Positive autoantibody serology test at screening.
- Contraception.
- Voluntarily sign the ICF.
Key exclusion criteria (5 listed)
- With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
- Possibly active Mycobacterium tuberculosis infection.
- With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
- Heavy drinking in the 3 months prior to screening.
- With depression or suicidal thoughts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM313 2 mg/kgOnce 1 week, intravenous infusion. | Biological | CM313 2 mg/kg |
| CM313 4 mg/kgOnce 1 week, intravenous infusion. | Biological | CM313 4 mg/kg |
| CM313 8 mg/kgOnce 1 week, intravenous infusion. | Biological | CM313 8 mg/kg |
| CM313 16 mg/kgOnce 1 week, intravenous infusion. | Biological | CM313 16 mg/kg |
| PlaceboOnce 1 week, intravenous infusion. | Biological | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Baseline up to Day 113
Safety parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 41290616Zhao J, Lin C, Xie Q, Shu Q, Cui Y, Luo H, Fan W, Huang A, Zhao Y, Fu Z, Xie C, Wu H, Yang N, He L, Feng P, Zhang T, Zhou H, Liu W, Hou Q, Mao X, Sun J, Chen B, Zeng X. Anti-CD38 monoclonal antibody CM313 for systemic lupus erythematosus: a randomized, double-blind, placebo-controlled phase Ib/IIa trial. Signal Transduct Target Ther. 2025 Nov 26;10(1):383. doi: 10.1038/s41392-025-02487-2.
Related trials for Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM313 2 mg/kg, CM313 4 mg/kg and CM313 8 mg/kg in people with Systemic Lupus Erythematosus, run by Keymed Biosciences Co.Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs). (time frame: Baseline up to Day 113). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.